- Collaborate with CSMs on maintenance of GCS operations-related documents for all active and upcoming studies (list below)
• Examples: checking for most current document versions, ensuring approval completeness, maintaining list of key study contacts, etc. - 2. Ensure accuracy and completeness of GCS study documents in team storage space (BOX and Sharepoint) by performing regular filing, review, and organization of controlled documents
- 3. Assist CSMs in managing document review and approval in DocuSign/ Adobe e-Sign
- 4. Interface with internal Client functions and external vendors (Almac, Catalent, PCI, Endpoint, etc) to obtain and maintain GCS study documents generated in day-to-day GCS operations
- 5. Streamline process for document storage and archiving across GCS studies by identifying and driving areas of improvement
- Support CSMs during audit and inspection activities by compiling and requesting study documents in anticipation of auditor/inspectors' requests a. Typically documents not already in BOX study folders.
- Collaborate with TMF specialist to ensure all TMF filings are accurate and contemporized for all GCS studies, particularly ahead of study audits and inspections.
- Assist CSMs with Storyboard creation and maintenance via communicating with involved functions and reviewing related study documents and/or TrackWise reports.
- Act as the GCS POC for document storage transition from Client BOX to Client BOX and OneDrive
- Create and maintain GCS documents in Vault, the GMP environment.
- Assist with PO requests in terms of Smartsheet submission and quote approval in Coupa Key GCS study documents:
- Request for Packaging (Blinded and Unblinded RFP)
- Variable Data Request
- Label Links and Rand
- Packaging Specifications (PS)
- Certificate of Compliance/Conformance (CoC)
- Certificate of Analysis (CoA), Certificate of Testing (CoT)
- Partial Manufacturing Certificate, QP certificates, IMP release Certificates
- Global Distribution Specifications (GDS)
- Drug Return Instructions (DRI), Certificate of Destruction (CoD) IRT: IRT specifications (Endpoint PULSE and Almac IXRS)
- Endpoint DRIVE Specifications
- User Acceptance Test (UAT) Log, IRT User guides
- DRIVE User Manual, Drug Return Instructions (DRI)
- Data Change Requests (DCR), IRT Report for Returns Discrepancy, IRT Validation Certificate
- Audit trail report requests for site/user changes for audits and inspections Study Maintenance: Study Protocol
- Pharmacy Manual (PM)
- Vendor Oversight Plan (VOP- GCS and study-level)
- Meeting Minutes, Purchase Order (PO) requests
- Clinical Supply Agreement (CSA) Quality (with GCSQ and external QA): Vendor Deviation Reports CSR: Appendix study lot information) Vault (Tentative): Clinical Label Approval Document (CLAD), Finished Product (FP) Specifications, Standard Operating Procedure (SOP) updates and lifecycle management Italicized items are tentative Disclaimer: This list is not comprehensive and is subject to change
-
Clinical Supply Chain Analyst
2 weeks ago
Integrated Resources New Haven, United StatesIntegrated Resources, Inc · New Haven, CT (Onsite) · Full-Time · Job Title: Clinical Supply Chain Analyst · Job Location: New Haven, CT (100% Remote) · Job Duration: 12 Months · Pay Range:$ 66.20/hr on w2. · Job Description: · Contributes to the planning and ongoing delivery ...
-
Supply Chain Planning Analyst|ALX|US
3 weeks ago
Artech New Haven, United StatesMBR @ *** 2 POSITIONS, CANDIDATES CAN BE F/T REMOTE, MSP CONTACT: KIMBERLY GARVEY. SEE ATTACHED JOB DESCRIPTION · Contributes to the planning and ongoing delivery of investigational products by managing the supply chain, supporting the execution of studies and changes to the plan ...
-
Supply Chain Analyst
3 weeks ago
Aston Carter Wilton, United States: This position will be responsible for overseeing achievement of tool usability (Calibration, Certification, Completeness) KPIs & Quality improvement programs. · You will also serve as deployment/implementation lead for quality initiatives, ensuring that US regional 3PL & CS te ...
-
Supply Chain Analyst
4 days ago
HN Ridgefield, United States**Supply chain analyst** · **Location**: Ridgefield Park NJ, CA (Hybrid) · **Contract Duration**: 6 Months extendable · **Essential Duties & Responsibilities**: · - Conduct transactional processes from factory to distribution center, making routine decisions using pre-determined ...
-
AP Analyst
4 days ago
Yale New Haven Health New Haven, Connecticut, United States PermanentOverview: · To be part of our organization, every employee should understand and share in the YNHHS Vision, support our Mission, and live our Values. These values - integrity, patient-centered, respect, accountability, and compassion - must guide what we do, as individuals and pr ...
-
GCS Document Specialist
3 weeks ago
MassGenics New Haven, United States ContractInnova Solutions is immediately hiring for a Supply Chain Planning Analyst · Position type: Full-time Contract · Location: (Remote) · Duration: 12+ Months · Note: Supply chain planning, shipment documentation experience · Vendor form and quality investigation · Must have clinical ...
-
GCS Document Specialist
3 weeks ago
Innova Solutions New Haven, United StatesInnova Solutions is immediately hiring for a Supply Chain Planning Analyst · Position type: Full-time Contract · Location: (Remote) · Duration: 12+ Months · Note: · Supply chain planning, shipment documentation experience · Vendor form and quality investigation · Must have ...
-
Trade Compliance Analyst
2 weeks ago
ASSA ABLOY New Haven, United StatesCareer Opportunities: Trade Compliance Analyst · Requisition ID · 27680 · - Posted · - · Sargent Manufacturing Company · - · Architectural Hardware Group · - · USA: Connecticut (New Haven - 100 Sargent Dr) · - · General Management · - · Posting Country (1) · - · Ye ...
-
Trade Compliance Analyst
2 weeks ago
ASSA ABLOY Sicherheitstechnik GmbH New Haven, United StatesJoin the ASSA ABLOY talent community and apply to be our next Trade Compliance Analyst. Experience an innovative culture that empowers you to build a career you can be proud of · In this role you'll get to work collaboratively with import and export brokers, ASSA ABLOY factories ...
-
Project Director, Conflict Analysis Programs
3 weeks ago
Yale University New Haven, United StatesEssential Duties · 1. Oversees the execution and implementation of detailed project plans in concert with stakeholders. 2. Manages several routine projects simultaneously and ensures that the design, testing, training, documentation and prioritization objectives are met. 3. Assi ...
-
Senior Tax Analyst
3 weeks ago
Veralto New Haven, United StatesPosition Title: Senior Tax Analyst · Imagine a world where everyone has access to clean water, safe food and medicine, and trusted essential goods. That is the tomorrow Veralto (NYSE: VLTO) is creating today. · Veralto is headquartered in Waltham, Mass. with 13 operating compan ...
-
Ap Analyst
4 days ago
Yale New Haven Health New Haven, United StatesOverview: To be part of our organization, every employee should understand and share in the YNHHS Vision, support our Mission, and live our Values. These values - integrity, patient-centered, respect, accountability, and compassion - must guide what we do, as individuals and prof ...
-
Inventory Analyst
23 hours ago
Insight Global North Haven, United StatesPay Rate: $21-22/hr This person will be joining the Operations team at a medical device company in New Haven County. As the Inventory Analyst, Service Operations, you will work on global efforts to align service inventory, facilitate product returns, transact service functions wi ...
-
Director, Financial Planning
1 week ago
Budderfly Shelton, United States Full timeSaving the World Help Wanted... · Budderfly is a fast-growth, private equity-backed energy management outsourcing company that is committed to reducing global carbon emissions for small to medium sized enterprises. We are the premier sustainability partner for businesses with re ...
-
Clinical Supervisor
1 week ago
Yai Connecticut, United States Full timePay range: $75,000-$85,000 annually · Key/Essential Functions & Responsibilities · Demonstrates and models professionalism and all skills of Lead Registered Behavior Technician (RBT) and of Direct Support Professional/Registered Behavior Technician (DSP/RBT) with a person-center ...
-
State of Connecticut Newington, United StatesIntroduction · The , Department of Transportation () invites experienced individuals to apply for the position of within the Office of the Commissioner - Division of Technology Services. · WE CAN OFFER YOU Visit our new page · Work for a Forbes top company: 'Forbes' - State ...
-
Sales Planning Analyst
41 minutes ago
Victorinox Swiss Army, Inc Monroe, United StatesJob Description · Job DescriptionPosition: Sales Planning Analyst · Objective: · The primary objective of this role is to generate and present reporting metrics that provide visibility and tracking into sales performance and objectives. The Sales Planning Analyst translates comp ...
-
Supply Chain Manager
1 week ago
KnowHireMatch Norwalk, United StatesSupply Planning Analytics Manager · Learn more about the general tasks related to this opportunity below, as well as required skills. · Are you ready to cook up a storm in our supply chain kitchen? As our Supply Planning Analytics Chef at a leading multi-billion-dollar food man ...
-
Global Soybean
1 week ago
Louis Dreyfus Wilton, United StatesCompany Description · Louis Dreyfus Company is a leading merchant and processor of agricultural goods. Our activities span the entire value chain from farm to fork, across a broad range of business lines, we leverage our global reach and extensive asset network to serve our cust ...
-
CH-53K Production Senior Finance Manager
6 days ago
Lockheed Martin Corporation Stratford, United StatesJob ID: 665512BR · Date posted: Apr. 23, 2024 · Description:We are committed to work life balance by promoting this HYBRID TELEWORK opportunity. These job requirements allow the employee to work at a Lockheed Martin-designated office or job site for part of their schedule and h ...
Clinical Supply Chain Analyst - New Haven, United States - Integrated Resources
Description
Job Title: Clinical Supply Chain AnalystJob Location: New Haven, CT (100% Remote)
Job Duration: 12 Months
Pay Range:$ 66.20/hr on w2.
Job Description:
Contributes to the planning and ongoing delivery of investigational products by managing the supply chain, supporting the execution of studies and changes to the plans, including carrying out risk assessments and contingency planning where necessary, in support of Clinical Therapy Area and non-Clinical Therapy Area projects. This is a Clinical Supply support role position, working directly with the Clinical Supply Manager to complete documentations in support of varying clinical activities.
GCS Document Specialist Day-to-day Operations